Evaluation of concentrations in hemacea, plasma and total magnesium in patients submitted to chemotherapy with platinum compounds in association with proton pump inhibitors and their correlation with neurological diseases

Phase 4

• Conditions: eoplasms; Malignant neoplasm of other parts of pancreas; Malignant neoplasm of rectum; Malignant neoplasm of splenic flexure; Malignant neoplasm of main bronchus; Undescended testis; Malignant neoplasm of ovary; Hodgkin's disease; Malignant neoplasm of head, face and neck; Malignant neoplasm of breast

• Registration Number: RBR-8vsb7k2
• Lead Sponsor: IVERSIDADE FEDERAL DO RIO GRANDE DO NORTE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-19
• Study Completion: 2021-04-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age over 18 years; Starting chemotherapy with a regime containing cisplatin, carboplatin or oxaliplatin; Chemotherapy regimen of 1 day or 5 consecutive days; Agree to participate by signing the Free and Informed Consent Form

Exclusion Criteria

Not having moderate to severe kidney disease or advanced disease with a life expectancy of less than 6 months; Having no history of hypersensitivity to any of the components of the omeprazole or placebo formulation; You must not have concomitant therapy with warfarin, atazanavir, tacrolimus or voriconazole; Patients taking diazepam, phenytoin or ampicillin may be included but the doses of these drugs should be adjusted.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find serum and total magnesium variations between the platinum groups associated with omeprazole compared to the placebo-associated platinum group and to identify possible neuropathic reactions using the Common Terminology Criteria for Adverse Events (CTCAE) severity rating - version 5.0 caused by magnesium deficiency

Secondary Outcome Measures

Name	Time	Method
Evaluate other correlations related to loss of magnesium or use of omeprazole, such as: Anemia and renal failure through the levels of creatinine and urea, benefit of using omeprazole in preventing gastrointestinal effects, as well as possible control measures and serum monitoring of magnesium medium and long term when possible